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Abingdon Analytical provides full performance evaluation study support, ensuring your regulatory requirements are met. Contact us today.
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Abingdon Analytical is a performance evaluation services provider based at a dedicated site in Doncaster and part of Abingdon Health plc. It supports developers of in vitro diagnostic (IVD) devices through performance studies designed to help meet regulatory requirements and advance submission pathways. Its services cover both analytical and clinical performance evaluation, with study plans informed by intended certification requirements, including FDA and IVDR.
Analytical assessments can examine sensitivity, specificity, interference and cross-reactivity, precision, matrix equivalence, measuring range, robustness, and stability, including shelf life, shipping, and in-use conditions. Clinical support includes clinical performance evaluation, clinical trials, and usability studies. The company also offers design and development support, helping clients address technical, financial, and regulatory obstacles during a project.
Abingdon Analytical works from its Doncaster laboratory and through a network of clinical trial sites across the UK, EU, and USA. Its multidisciplinary team applies guidance and standards including CLSI, ICH, and ISO.
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Health
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The Abingdon Health name, logos and brand assets are trademarks of Abingdon Health and its affiliates. Brandfetch isn't affiliated with or endorsed by Abingdon Health. Their use is subject to Abingdon Health's brand guidelines.
